Stryker · 1 week ago
Director, Regulatory Affairs - Pharmaceuticals
Massachusetts, Virtual Address
Full-time
Hybrid
Director/Executive
$167K/yr - $362K/yr
15+ years expStryker is a leading company in the pharmaceuticals sector, and they are seeking a Director of Regulatory Affairs to lead their regulatory affairs team. The role involves developing regulatory strategies for drug products, managing a team, and ensuring compliance with regulatory requirements while interacting with various departments and regulatory agencies.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Serves as member of the extended business unit leadership team. Able to effectively communicate, interact, and navigate issues at leadership level
Creates long term regulatory strategy for drug products, provides input on combination products, and identifies team needs by understanding the industry and regulatory landscape in combination with the business priorities and goals
Manages a regulatory affairs team responsible for the division’s pharmaceutical products. Hires, trains, develops, coaches/ mentors and motivates staff. Conducts performance management
Accountable for the regulatory strategy, requirements, deliverables, and results to support drug development both domestically and internationally. Regulatory pathways may include INDs, NDA or sNDA, DINAs, etc
Provides regulatory guidance to and interacts with Marketing, Clinical, Legal, Operations, Compliance and R&D leadership
Leads team in development and implement pharmaceutical quality system and process requirements for business in order to ensure compliance to external regulations and standards. Responsible for commercial drug product disposition and release in addition to Quality Assurance responsibilities. Viewed as pharmaceutical regulatory expert within business
Leads communication with FDA and other regulatory agencies to gain alignment on most efficient regulatory pathways and gain product approvals. Represents pharmaceutical aspects in external agency audits/inspections
Stays abreast of external pharmaceutical regulatory requirements and expectations
Qualification
Required
Bachelor's degree (B.S. or B.A.) in Engineering, Science, or related
Minimum 15 years of experience, including 10 years in an FDA regulated industry
Experience with successful NDA and DINAs
Ability to analyze complex data
Ability to analyze and understand regulatory requirements and standards
Ability to communicate and present to various stakeholders, both internally and externally
Strong organizational skills
Self-initiated
Demonstrated ability to lead complex cross functional teams and projects
Preferred
RAC certification or Advanced Degree (Masters in Regulatory Affairs)
5 years of managerial experience preferred
Prefer additional experience with IDEs/ 510(k)s and/or combination products
Benefits
Bonus eligible
Generally eligible for short-term and long-term financial incentives
Benefits
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chair & CEO
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase